12 HOUR ORIGINAL NASAL DECONGESTANT- nasal spray liquid

12 Hour Original Nasal Decongestant by

Drug Labeling and Warnings

12 Hour Original Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient
Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

Tempoarily relieves nasal congestion due to:

• common cold
• hay fever
• sinusitis
• upper respiroty allergies
• Shribnk swollen membranes so you can breathemore freely

Warnings

Ask a Doctor before use if you have

• heart diease
• high blood pressure
• diabetes
• thyiod diease
• trouble urinating due to enlarged rostate gland.

When using this product

• Do not use more than directed
• do not use for more than three days, Use onyl as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• temporary discomfort such as burning ,stinging, sneezing or an increase in nasal discharge may occur.
• use of this container by more thna one person may spread infection.

stop use and ask a doctor if

symptoms persist.

PREGNANCY

ask a health professional before use.

Keep out of the reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

• Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age consult a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.

Other information

• store between 20° and 25°C (68° to 77°F)
• retain carton for future reference on full labeling

INACTIVE INGREDIENT

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Principal display panel- Bottle

Lee

Relieves Conmgestion

Nasal Spray original 12 hour relief

Oxymetazoline HCL Nasal SolutionNasal Decongestant

1 FL OZ (30 ml)

Principal display panel- Bottle back label

Principal display panel -Carton

Lee

Relieves Conmgestion

Nasal Spray  original 12 hour relief

• Oxymetazoline HCL Nasal Solution
• Nasal Decongestant

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

12 HOUR ORIGINAL NASAL DECONGESTANT 
nasal spray liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-140
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	50 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POVIDONE K29/32 (UNII: 390RMW2PEQ)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-140-55	1 in 1 CARTON	05/30/2014
1		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/30/2014

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(11527-140)